Bonipar for Acute and Chronic Musculoskeletal Pain

This study is a non-inferiority study comparing efficacy and onset of action between the
herbal extracts topical solution, Bonipar, and diclofenac sodium topical solution, diclofenac
gel 1% (approved by the FDA as a topical analgesic). Approximately 168 Duke patients will be
recruited from Duke Pain Clinic, and selected Duke primary care practices. Individuals who
report acute (less than 3 months duration) or chronic musculoskeletal pain of any intensity
will be considered for enrollment into the study. After obtaining consent, eligible subjects
will be will be randomized to receive Bonipar or diclofenac gel 1%.

INCLUSIONARY CRITERIA:

- Subject with acute and chronic localized musculoskeletal pain

- Ages 18 to 80 years

- Subjects of all races, gender or ethnic groups

- Female subjects of childbearing age must have a negative pregnancy test Female
subjects of childbearing age who are sexually active must agree to use appropriate
contraceptive measures for the duration of the study. Medically acceptable
contraceptives include: (1) surgical sterilization (such as tubal ligation or
hysterectomy), (2) approved hormonal contraceptives (such as birth control pills,
patches, implants or injections), (3) barrier methods (such as a condom or diaphragm)
used with a spermicide, or (4) an intrauterine device (IUD).

- Willing to provide written informed consent

- Patients taking opioid or NSAID for their musculoskeletal pain may be included if pain
is inadequately controlled

EXCLUSIONARY CRITERIA:

- Patients meeting any of the following criteria will be excluded from the study: Use
within 3 days of any topical agents on the affected area

- Subject with active skin lesions or skin disease or with cutaneous manifestations of
systemic illnesses

- Subject with history of uncontrolled diabetes (A1C of more than 9)

- Subject with history of uncontrolled hypertension (SBP > 160 and DBP > 95)

- Subject with active uncontrolled GERD (defined as more than 2 episodes per week) or
history of peptic ulcer disease

- Subject with active cancer, spinal cord lesions or spine surgery

- Subject with allergies to diclofenac or to other non-steroid anti-inflammatory drugs
(NSAID)

- Known allergies to any oils, methyl salicylate and/or camphor

- Subject is pregnant or lactating

- Subject with history of heart attack, stroke or blood clot, or recent coronary artery
bypass graft surgery (CABG) (i.e., within the last six months)

- Subject with history of alcohol or drug abuse within 1 year

- Subject with history of severe cardiac, liver or kidney disease or any other medical
condition that may interfere with the subject's ability to participate in the study as
determined by the Investigator